Leslie K. Ball, MD, CAPT, USPHS, Director, Division of Scientific Investigations, Office of Compliance, CDER, FDA will present the FDA's expectations for clinical CAPAs.
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The FDA requires that sponsors report findings from monitoring, present the corrective action and prove that a process has been established to prevent the deviation from recurring. Are you securing compliance, or do your monitoring issues appear to languish and recur from visit-to-visit with no detailed plan? Dr. Ball will provide additional detail regarding the agency’s expectations and information on current inspection trends and follow-up. She is scheduled to comment on:
- Commonly occurring deficiencies in CAPA
- Event identification at the site level: What documentation is essential at the site versus at the sponsor level?
- How to create a useful and meaningful "Note-to-File" document
- How CAPA systems can be leveraged to support site inspections
- Providing an acceptable response to an FDA 483 or Warning Letter: What has and has not been deemed acceptable
Key Questions our Faculty Will Address over the Two-Day Conference Include:
- What are CAPA events in the clinical environment beyond protocol violations?
- How are data quality problems viewed in a CAPA system?
- What "events" other than audit findings should drive clinical CAPA? e.g., monitoring findings, other types of deviations, complaints about investigator sites, statistical analysis, other intelligence
- How do you effectively document the CAPA? Whose responsibility is it to identify and manage them? Who evaluates the quality of the CAPA responses?
- How do you follow through on the corrective and preventive actions to ensure they have been effectively closed out? Are there proactive ways to assess potential problems for CAPAs (eg, while mapping processes and writing SOPs) as opposed to waiting for the issues to occur and then having to create the CAPAs?
Don’t Miss the Opportunity to Influence this CAPA Discussion
Attend our 2-day inaugural conference to join this valuable dialog. Start the process of setting goals and standards around clinical CAPAs, ultimately to support your company’s overall clinical quality efforts.
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